La Jolla reports results for Phase 3 heart med study

May 22, 2017

La Jolla Pharmaceutical Company (Nasdaq: LJPC) (La Jolla) today announced that results of the ATHOS-3 (Angiotensin II for the Treatment of High-Output Shock) Phase 3 study of LJPC-501 (angiotensin II) have been published online by The New England Journal of Medicine (NEJM). The article, entitled “Angiotensin II for the Treatment of Vasodilatory Shock,” also will be published in the May 25, 2017 print issue of NEJM.

“There is a major need for new treatment options for critically ill patients who do not adequately respond to available vasopressors,” stated Rinaldo Bellomo, M.D., Professor of Intensive Care Medicine at University of Melbourne and Director of Intensive Care Research at Austin Health. “In ATHOS-3, angiotensin II was shown to raise blood pressure with no increase in overall adverse events as compared to placebo in this highly treatment-resistant patient population. The effect of angiotensin II resulted in reduced use of other vasopressors. If approved, angiotensin II, in combination with other vasopressors, may allow clinicians to leverage all three major physiologic systems that regulate blood pressure.”

The analysis of the primary efficacy endpoint of ATHOS-3, defined as the percentage of patients achieving a mean arterial pressure (MAP) ≥ 75 mmHg or a 10 mmHg increase from baseline MAP at 3 hours following the initiation of study treatment without an increase in standard-of-care vasopressors, was statistically significant: 23.4% of the 158 placebo-treated patients achieved the pre-specified blood pressure response, compared to 69.9% of the 163 angiotensin II-treated patients (p<0.001). In addition, a trend toward longer survival was observed for angiotensin II-treated patients (22% reduction in mortality risk through day 28; hazard ratio=0.78 [CI: 0.57, 1.07; p=0.12]). In this critically ill patient population, 91.8% of placebo-treated patients experienced at least one adverse event, compared to 87.1% of angiotensin II-treated patients, and 21.5% of placebo-treated patients discontinued treatment due to an adverse event, compared to 14.1% of angiotensin II-treated patients.